Trial of Hypofractionated Radiation Therapy for Glioblastoma
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|ClinicalTrials.gov Identifier: NCT02206230|
Recruitment Status : Recruiting
First Posted : August 1, 2014
Last Update Posted : January 5, 2016
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma||Radiation: Hypofractionated radiation therapy Radiation: Standard radiation therapy||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||132 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Controlled Trial of Conventional Versus Hypofractionated Radiation Therapy With Temozolomide for Patients With Newly Diagnosed Glioblastoma|
|Study Start Date :||August 2014|
|Estimated Primary Completion Date :||August 2019|
|Estimated Study Completion Date :||August 2020|
Experimental: Hypofractionated radiation therapy
Hypofractionated radiation therapy of 60 Gy in 20 fractions (3 Gy per fraction) with concurrent temozolomide 75 mg/m2 given 7 days/week. After a 4-week break, temozolomide days 1-5 every 28 days for 6 cycles.
Radiation: Hypofractionated radiation therapy
Active Comparator: Standard radiation therapy
Standard radiation therapy of 60 Gy in 30 fractions (2 Gy per fraction) with concurrent temozolomide 75 mg/m2 given 7 days/week. After a 4-week break, temozolomide days 1-5 every 28 days for 6 cycles.
Radiation: Standard radiation therapy
- Overall survival [ Time Frame: Up to 24 months from date of randomization to date of death due to any cause ]Patients without an event will be censored the last time they were known to be alive
- Progression-free survival (PFS) [ Time Frame: Up to 24 month where PFS is defined as the time between randomization and radiographic progression based on RECIST criteria or death due to any cause. ]Patients without an event will be assessed at the date of last follow-up for progression. Patients with no post-baseline follow-up for progression will be censored at the day of randomization.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02206230
|Contact: Samir Patel, MDfirstname.lastname@example.org|
|Cross Cancer Institute||Recruiting|
|Edmonton, Alberta, Canada, T6G 1Z2|
|Contact: Samir Patel, MD 780-432-8518 email@example.com|
|Principal Investigator:||Samir Patel, MD||Cross Cancer Institute|